Daclizumab trial results
Posted: Tue Aug 21, 2007 12:05 am
Not sure of the status of this trial (says Phase II). Small number of patients, but promising results for those where interferon not doing the job.
Daclizumab phase II trial in relapsing and remitting multiple sclerosis
MRI and clinical results
Objective: Daclizumab is an interleukin 2 receptor chain specific humanised monoclonal antibody that has shown promising therapeutic effects in multiple sclerosis (MS). Daclizumab treatment in patients with relapsing and remitting MS was administered to determine effects on MRI and clinical outcomes.
Methods: Patients with MS on interferon (IFN) therapy but with continuing relapses and contrast enhancing lesions (CEL) were selected. Patients were evaluated with monthly MRI scans and clinical rating scales starting 3 months prior to treatment and then at 0.5 to 27.5 months during treatment. Daclizumab (1 mg/kg IV) was administered twice in the first month (initiated and administered again in 2 weeks), followed by treatments every 4 weeks. IFN was continued until 5.5 months after daclizumab was initiated. Patients were then placed on daclizumab monotherapy. Patients with recurrent CEL were restarted on IFN with daclizumab therapy at (1.5 mg/kg IV) every 28 days.
Results: Nine patients qualified for inclusion and completed the trial. Efficacy measured by both total CEL and new CEL (p < 0.001), relapses, timed ambulation, Expanded Disability Status Scale, and Neurologic Rating Scale (p < 0.05 to p < 0.01) was observed.
Conclusion: Daclizumab was effective in reducing contrast enhancing lesions and improving clinical scores in patients with relapsing and remitting multiple sclerosis with active disease not controlled by interferon therapy. These results provide evidence for long-term efficacy and support further clinical development of daclizumab.
J. W. Rose, MD, J. B. Burns, MD, J. Bjorklund, CCRC, J. Klein, APRN, H. E. Watt, BS and N. G. Carlson, PhD From the Neurovirology Research Laboratory (J.W.R., J.B.B., J.B., J.K., H.E.W., N.G.C.) and Geriatric Research Education Clinical Center (N.G.C.), Veterans Affairs Salt Lake City Health Care System, and Departments of Neurology (J.W.R, J.B.B., J.K., N.G.C.) and Neurobiology and Anatomy (N.G.C.) and Brain Institute (J.W.R., N.G.C.), University of Utah, Salt Lake City.
Source: NEUROLOGY © 2007 American Academy of Neurology (21/08/07)
Daclizumab phase II trial in relapsing and remitting multiple sclerosis
MRI and clinical results
Objective: Daclizumab is an interleukin 2 receptor chain specific humanised monoclonal antibody that has shown promising therapeutic effects in multiple sclerosis (MS). Daclizumab treatment in patients with relapsing and remitting MS was administered to determine effects on MRI and clinical outcomes.
Methods: Patients with MS on interferon (IFN) therapy but with continuing relapses and contrast enhancing lesions (CEL) were selected. Patients were evaluated with monthly MRI scans and clinical rating scales starting 3 months prior to treatment and then at 0.5 to 27.5 months during treatment. Daclizumab (1 mg/kg IV) was administered twice in the first month (initiated and administered again in 2 weeks), followed by treatments every 4 weeks. IFN was continued until 5.5 months after daclizumab was initiated. Patients were then placed on daclizumab monotherapy. Patients with recurrent CEL were restarted on IFN with daclizumab therapy at (1.5 mg/kg IV) every 28 days.
Results: Nine patients qualified for inclusion and completed the trial. Efficacy measured by both total CEL and new CEL (p < 0.001), relapses, timed ambulation, Expanded Disability Status Scale, and Neurologic Rating Scale (p < 0.05 to p < 0.01) was observed.
Conclusion: Daclizumab was effective in reducing contrast enhancing lesions and improving clinical scores in patients with relapsing and remitting multiple sclerosis with active disease not controlled by interferon therapy. These results provide evidence for long-term efficacy and support further clinical development of daclizumab.
J. W. Rose, MD, J. B. Burns, MD, J. Bjorklund, CCRC, J. Klein, APRN, H. E. Watt, BS and N. G. Carlson, PhD From the Neurovirology Research Laboratory (J.W.R., J.B.B., J.B., J.K., H.E.W., N.G.C.) and Geriatric Research Education Clinical Center (N.G.C.), Veterans Affairs Salt Lake City Health Care System, and Departments of Neurology (J.W.R, J.B.B., J.K., N.G.C.) and Neurobiology and Anatomy (N.G.C.) and Brain Institute (J.W.R., N.G.C.), University of Utah, Salt Lake City.
Source: NEUROLOGY © 2007 American Academy of Neurology (21/08/07)